Home NDC 25021-235-51 gemcitabine
Product NDC 25021-235
Requested package NDC 25021-235-51
11-digit product format 250210235
Labeler code 25021
Product ID 25021-235_95123b19-2847-4cb8-8736-ecca1399bb81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gemcitabine hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA202485
Marketing category ANDA
Marketing start 2014-12-29
Substance GEMCITABINE HYDROCHLORIDE
Active strength 1 g/25mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202485-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 A202485-002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 90 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-11-14 07:37:17 2026-10 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202485-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202485-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2013-05-07 5d02ea3f76ae…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base gemcitabine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMCITABINE HYDROCHLORIDE 1 g/25mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U347PV74IL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1719000 Internal RxNorm lookup 1719003 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-235-50 gemcitabine 25 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 25 12 25021-235-50 gemcitabine 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 25021-235-51 gemcitabine 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 12 25021-235-51 gemcitabine 25 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 25 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded gemcitabine hydrochloride ACTIVE INGREDIENT U347PV74IL GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 gemcitabine ACTIVE MOIETY B76N6SBZ8R GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 hydrochloric acid INACTIVE INGREDIENT QTT17582CB GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 sodium acetate INACTIVE INGREDIENT 4550K0SC9B GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-235 GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 12 Current NDC, Legacy NDC, 4 package rows 20240918_44bcc16c-341d-49e8-a1c6-95d084667aca.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-235-51 25021023551 10 VIAL in 1 CARTON (25021-235-51) / 25 mL in 1 VIAL 10 vial 2022-12-15 0000-00-00 No No Current